Life in the Lab – Microbiology Team Leader

Part of my Life in the Lab Series.

Here I summarise what each of my scientific roles have entailed.

As a Microbiology Team Leader (non sterile laboratory), what does the day entail?

08:30 hrs – Start shift

  • Check how everyone is going today
  • Determine what needs to be done in next two months and delegate
  • Spot check equipment calibration labels
  • Conduct sampling of Purified Water system if short staffed
  • Followup with other departments regarding on going projects
  • Update documentation or delegate and meet with subject matter experts
  • Check and signoff on environmental monitoring data (worksheets) or delegate
  • Ensure any followup sampling has been completed, if not find out why and reschedule
  • Interview prospective staff

10:30hrs – 15 minute break

  • Check how everyone is going
  • Validation and introduction of equipment such as dust containment hoods and flammable liquid containers
  • After developing, deliver special training to production, eg Microbiology for non-microbiologists
  • Conduct antibiotic potency testing if short staffed (also method trouble shooting)
  • Read and record viable environmental monitoring results if short staffed
  • Train staff in sampling techniques or delegate
  • Pursue special projects or delegate
  • Sign off on environmental monitoring data
  • Delegate the testing of “urgent samples” and manage expectations of requestor
  • Meet with product representatives
  • Schedule and chair regional meeting of microbiologists as part of information sharing and method harmonisation
  • Conduct performance reviews of team

12:30hrs – 45 minute lunch

  • Check how everyone is going
  • Schedule or delegate external testing
  • Review the regulations for gaps and improvements
  • Formulate media if short staffed
  • Meeting with production managers, supervisor and filling room staff as part of out of specification results investigation
  • Write investigation reports
  • Deliver training to team (routine and special)
  • Conduct investigative monitoring or delegate
  • Investigate and report on environmental monitoring trends

15:30hrs – 15 minute break

  • Check how everyone is going
  • Attend site consolidation project meetings
  • Conduct internal audit (about every 6 months based on schedule)
  • Ensure OH&S is being followed (this is a constant thing every time I enter then lab)
  • Continue tasks from earlier in the day
  • Contribute to yearly budget
  • Catch up meeting with lab manager
  • Travel to other company sites in same city for meetings
  • Examine training status of team and schedule training / update records
  • Issue updated documentation and train staff if training required
  • Determine if tasks scheduled for tomorrow
  • Determine if there is anything that needs the later afternoon shift or night shift to be aware of

17:00 – Depart for home

Roles Held

Microbiology TechnicianMicrobiology AnalystSenior Microbiologist aka “Microbiology Officer”Quality Assurance Microbiologist – Non Sterile Microbiology Team Leader

TGA Inspection Trends

My reply to a post on LinkedIn.

Current TGA Inspection trends: This presentation will focus on the common types of deficiencies found by the TGA’s GMP Inspectors as well as some data on the number of inspections performed both locally and overseas and compliance rating outcomes for the inspections performed.

Comment 1 stated “…there are patterns that seem to repeat year after year. Poor QMS, inadequate investigations, lack of training.”

My reply to this was:

“The PIC’S guide to GMP stresses the need for a robust QMS and repeats over and over again the need for documentation, solid investigations and adequate training and retraining. It is a wonder why citations regarding a lack of these keep being given.” Continue reading

Notes on Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002)

When it was current, I reviewed the Australian code of good manufacturing practice for medicinal products (16 August 2002) so I was aware of the pertinent details in relation to viable environmental monitoring and testing.

The Australian Code of Good Manufacturing Practice for Medicinal Products 2002 was revoked effective from 1 July 2010 and replaced by the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, as adopted in Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009. The 2002 GMP Code for Medicinal Products remains available here for comparison purposes. Continue reading